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PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT02730312
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Xencor, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia B-cell Acute Lymphoblastic Leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm Chronic Myeloid Leukemia, Blast Crisis Biological: XmAb14045 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: XmAb14045
Biological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks
 Biological: XmAb14045
Administered IV weekly up to 8 weeks, with or without induction dosing


Outcome Measures
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Primary Outcome Measures :
  1. Safety as determined by the number of participants with treatment-related adverse events [ Time Frame: Baseline Day 1 through Day 56 ]
    Treatment-related adverse events as assessed by CTCAE v4.03

  2. Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing [ Time Frame: Baseline Day 1 through Day 56 ]
    Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of 1 of the following diseases:

    • Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
    • B-cell ALL
    • BPDCN
    • CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy
  • Patients with relapsed or refractory disease with no available standard therapy
  • ECOG performance status 0-2
  • Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation
  • Fertile patients must agree to use effective contraception during and for 4 weeks after completion of study
  • Able and willing to complete the entire study

Exclusion Criteria:

  • Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
  • Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
  • Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement)
  • Known uncontrolled central nervous system involvement by malignant disease
  • Absolute blast count ≥10,000/mm3 or symptoms of leukostasis
  • Diagnosis of promyelocytic leukemia
  • Aspartate aminotransferase or alanine aminotransferase at screening >3.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement
  • Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome
  • Serum creatinine >2.0 x ULN, or estimated creatinine clearance <40mL/min
  • History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation
  • Evidence of any active, uncontrolled bacterial, viral, parasitic fungal infections within 1 week of first dose of study drug
  • Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine
  • Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730312


Locations
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United States, Florida
Mayo Clinic Jacksonville Florida
Jacksonville, Florida, United States, 32224
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Xencor, Inc.
Chiltern International Inc.
Investigators
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Study Director: Wayne Saville, MD VP, Oncology Clinical Development, Xencor, Inc.
More Information
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02730312     History of Changes
Other Study ID Numbers: XmAb14045-01
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xencor, Inc.:
AML
B-ALL
BPDCN
CML
Blast Crisis

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Burkitt Lymphoma
Blast Crisis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes